Gilead Nixes Leukemia Phase 3 Trial

Gilead Sciences is discontinuing its Phase 3 ENHANCE-3 study of magrolimab in acute myeloid leukemia (AML) after FDA placed all magrolimab studies in myelodysplastic syndromes and AML, including related expanded access programs, on full clinical hold. The company’s and FDA’s decisions follow an independent data monitoring committee’s review of interim results showing that the drug “demonstrated futility with an increased risk of death in the magrolimab-treatment arm,” Gilead says.

“Patients in the ENHANCE-3 study will discontinue treatment with magrolimab and Gilead is communicating with investigators to determine appropriate next steps for patients in the study,” the company says. “Sub-analyses of ENHANCE-3 for efficacy and safety are ongoing and results will be shared with regulatory authorities and will be submitted for presentation at an upcoming medical meeting and/or publication in a peer-reviewed journal.”